Method for treatment of hair loss with a combination of natural ingredients

ABSTRACT

The invention provides a composition for topical treatment of hair loss/alopecia including three natural, active ingredients, caffeine, saw palmetto berry extract, and epigallocatechin-3-gallate (EGCG). The invention also provides methods for using this composition to treat hair loss.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. ProvisionalPatent Application No. 61/441,063, filed on Feb. 9, 2011, and to U.S.Provisional Patent Application No. 61/496,071, filed on Jun. 13, 2011,the contents of which are hereby incorporated by reference in theirentirety.

This application is related to U.S. Utility Patent Application No.11/242,207, filed on Oct. 3, 2005, now abandoned, the content of whichis hereby incorporated by reference in its entirety.

The foregoing applications and all documents cited therein or duringtheir prosecution, and all documents cited or referenced herein,together with any manufacturer's instructions, descriptions, productdescriptions, and product sheets for any product mentioned herein or inany document incorporated by reference herein, are all herebyincorporated herein by reference, and may be used in the practice of theinvention.

FEDERAL SPONSORSHIP

This work was not federally sponsored research or development.

FIELD OF THE INVENTION

The invention generally relates to compositions and methods for treatinghair loss, particularly to compositions for treating hair loss byreducing the effects of 5α-dihydrotestosterone (DHT), and mostparticularly to compositions for treating hair loss including threenatural, active ingredients, caffeine, saw palmetto berryextract/derivative, and epigallocatechin-3-gallate (EGCG).

BACKGROUND

Millions of Americans experience some degree of alopecia, commonlyreferred to as “balding” or simply “hair loss”, resulting inever-increasing amounts of money being spent in efforts to stop the lossand/or grow the hair back.

Countless pharmaceutical remedies, cosmetic treatments, and surgicalmethods of varying success have been devised in order to address theproblem of hair loss. The difficulty in identifying effective treatmentsstems from the fact that there is no one cause for hair loss, butrather, there are many, such as: hormonal changes, heredity, disease,stress, medications, infections, genetic disorders, toxic agents, and/orfood deficiencies.

The majority of cases are hormonal in origin, for example—androgenicalopecia (also known as male-pattern alopecia and androgeneticalopecia), which is a distressing problem for a large proportion ofadult men. This male balding most often starts between the ages of 30-50years old. Occasionally, it may begin at an even younger age.

In men developing androgenic alopecia, there is a gradual atrophy ofhair follicles due to a genetically-inherited sensitivity to5α-dihydrotestosterone (also know as “dihydrotestosterone” or “DHT”).The enzyme 5-α-reductase transforms testosterone intodihydrotestosterone in the hair follicles, which then directs folliclesto progressively shrink and finally disappear. Thus, considering that5α-dihydrotestosterone is a key contributing factor to the onset andprogression of androgenic alopecia, blocking DHT is an area of interestfor protecting hair.

Although there are currently many accepted oral and topical treatmentsfor balding, only two drugs have been approved by the Food and DrugAdministration (FDA) to treat alopecia; topical minoxidil (trademarkname—Rogaine®) and oral finasteride (trademark name—Propecia®).

Minoxidil, (trademark name—Rogaine®), was originally developed as atreatment for individuals with high blood pressure. While treating theseindividuals, it was discovered that minoxidil moderately increased hairgrowth and prevented future hair loss. It is also believed thatminoxidil may increase hair growth in thinning hair areas, but themechanism of action (of minoxidil) remains unknown.

However, although these advantages of use exist, there are problemsassociated with the use of minoxidil. The most common side effect oftopical minoxidil is skin irritation and/or a local allergic reactioncalled contact dermatitis. Additionally, if the medication is stoppedafter prolonged use, hair loss may actually increase rather thandecrease. Further, major complications of minoxidil are rare, butpossible, and can include decreased blood pressure with headache,fatigue, and dizziness. Patients who suffer from heart disease orhypertension cannot utilize minoxidil without medical supervision.

Minoxidil in lower concentration is a non-prescription product currentlysold over-the-counter in multiple different formulations for treatmentof hair loss in both men and women.

The second FDA-approved drug is finasteride (trademark name—Propecia®).Finasteride was originally used to treat prostate enlargement byinhibiting the 5-α reductase enzyme. The inhibition of the 5-α reductaseenzyme interferes with the formation of DHT by blocking the action of5-α reductase on testosterone. Men undergoing this treatment experiencedan increase in hair growth. It is believed that the inhibition of the5-α reductase enzyme may increase hair follicle growth or prevent futurehair follicle loss.

However, although these advantages of use exist, there are also problemsassociated with the use of finasteride. Men may experience decreasedlibido, decreased volume of ejaculate, and a lowered level of prostatespecific antigen (PSA). This lowered level of PSA may interfere withscreening for prostate cancer.

Further, pregnant or nursing women may not use finasteride because it isteratogenic, and can harm the human fetus. Due to such a serious healthrisk, finasteride has been limited to use within male patientpopulations only, leaving a majority of female alopecia sufferers toseek alternative treatment options.

A topical treatment for androgenic alopecia will have lower internalexposure leading to a lower internal side effect profile than oralmedications such as finasteride. Currently available topicalmedications, i.e. minoxidil, have not worked consistently or effectivelyfor balding. In theory, topical medications targeted at interfering withthe production of testosterone derivatives or blocking the effects ofdihydrotestosterone on its receptor (stopping the trigger ofmale-pattern hair loss) would be beneficial, but to date, none have beensatisfactorily successful.

For additional background information regarding hair loss/alopecia, seeU.S. Pat. Nos. 6,878,145 B2; 7,713,557 B2; and 8,080,524 B2.

Citation or identification of any reference/document in the instantapplication is not and should not be interpreted as an admission thatsuch reference/documents is available as prior art to the presentinvention.

SUMMARY OF THE INVENTION

The invention provides a topical composition for improving treatmentsfor human hair loss (alopecia) by reducing the effects of5α-dihydrotestosterone (DHT) and thus, enhancing hair loss preventionand/or hair growth promotion.

The terms “hair loss”, “alopecia”, “balding”, and “pattern hair loss”are used interchangeably herein.

A “topical composition” or “topical formulation” refers to a productthat is applied externally to a part of the body and/or is applied onlyon the surface. Thus, topical treatments limit exposure to a local areaand avoid systemic exposure.

The composition includes three natural, active ingredients, caffeine,saw palmetto berry extract/derivative, and epigallocatechin-3-gallate(EGCG) which work directly at the site of the pathway, i.e. conversionof testosterone to dihydroxytestosterone by 5-α-reductase, for patternalopecia.

In one embodiment of the invention, the composition is a liquid in theform of a shampoo, a conditioner, a tonic, a combinationshampoo/conditioner, or a combination shampoo/conditioner/tonic.

Shampoo, as used herein, refers to compositions that are known in theart as shampoos. A shampoo is a composition that is applied to the scalpor hair for the general purpose of cleaning the scalp and/or hair.Shampoos may include various components known in the art, for example,but not limited to, soap, cleansers, detergents (sodium lauryl sulfate),surfactants, fragrances, anti-dandruff agents, thickening agents,humectants, moisturizers, glycol, polysorbate, and/or citric acid.

Conditioner, as used herein, refers to compositions that are known inthe art as conditioners. A conditioner is a composition that is appliedto the scalp or hair for the general purpose of conditioning the scalpor hair, for example, but not limited to, improving texture or tone,de-tangling, lubricating, softening, moisturizing, thickening, and/orimproving shine. Conditioners may include various components known inthe art, for example, but not limited to, glossers (silicone compounds),polyalkylene glycol, reconstructors, thermal protectors, lubricants(panthenol), acidifiers, oils, preservatives, and/or anti-static agents.Conditioners can be the rinse-off type or the leave-in (not rinsed off)type.

Tonic, as used herein, refers to a solution, liquid, foam, or gelapplied to the scalp to improve hair without providing the benefits of ashampoo and/or conditioner.

As used herein, the combination shampoo/conditioner or the combinationshampoo/conditioner/tonic refers to compositions that combine thecharacteristics of a shampoo and conditioner or the characteristics of ashampoo, conditioner, and tonic, respectively.

In another embodiment of the invention, the composition is adermatological composition associated with the integumentary system,i.e. skin, hair, and/or nails.

In another embodiment of the invention, the composition is acosmeceutical composition that is available to the publicover-the-counter (without the requirement of a prescription) and used toimprove the integumentary system.

In one embodiment, the invention provides a topical hair treatment inwhich the treatment is a liquid in the form of a shampoo, a conditioner,a tonic, a combination shampoo/conditioner, or a combinationshampoo/conditioner/tonic and includes approximately 0.01 to 0.19 mg/mlof caffeine (0.001% to 0.19% weight of caffeine/final volume).

As used herein, 1% weight=1000 mg per 100 ml final volume.

The caffeine included in the composition can be hydrous caffeine,caffeine salts, or complexes breaking down to yield caffeine.

In accordance with another feature of the invention, the caffeine isincluded in the liquid composition in an amount of approximately 0.1mg/ml (0.01% weight of caffeine/per final volume).

In another embodiment, the invention provides a topical hair treatmentin which the treatment is a liquid in the form of a shampoo, aconditioner, a tonic, a combination shampoo/conditioner, or acombination shampoo/conditioner/tonic and includes approximately0.01mg/ml to 0.2 mg/ml of a saw palmetto berry derivative (0.001% to0.02% weight of saw palmetto berry derivative/final volume).

The saw palmetto berry derivative included in the composition can be asaw palmetto berry extract or a hydrous saw palmetto berry extract.

In accordance with another feature of the invention, the saw palmettoberry derivative is included in the liquid composition in an amount ofapproximately 0.1 mg/ml (0.01% weight of saw palmetto berryderivative/per final volume).

In another embodiment, the invention provides a topical hair treatmentin which the treatment is a liquid in the form of a shampoo, aconditioner, a tonic, a combination shampoo/conditioner, or acombination shampoo/conditioner/tonic and includes approximately 0.5mg/ml to 50 mg/ml of an epigallocatechin-3-gallate (EGCG) derivative(0.05% to 5% weight of EGCG/final volume).

The epigallocatechin-3-gallate (EGCG) derivative included in thecomposition can be an extract powder, an extract liquid, or alyophilized power extracted using water and pure grain alcohol.

In accordance with another feature of the invention, theepigallocatechin-3-gallate (EGCG) derivative is included in the liquidcomposition in an amount of approximately 2.5 ml/mg (0.25% weight ofEGCG/per final volume).

In yet another embodiment, the invention provides a topical hairtreatment in which the treatment is a liquid in the form of a shampoo, aconditioner, a tonic, a combination shampoo/conditioner, or acombination shampoo/conditioner/tonic and includes approximately 0.01 to0.19 mg/ml of caffeine (0.001% to 0.19% weight of caffeine/finalvolume); approximately 0.01mg/m1 to 0.2 mg/ml of a saw palmetto berryderivative (0.001% to 0.02% weight of saw palmetto berryderivative/final volume; and approximately 0.5 mg/ml to 50 mg/ml of anepigallocatechin-3-gallate (EGCG) derivative (0.05% to 5% weight ofEGCG/final volume).

The instant invention also provides a method for treating hair loss in ahuman subject undergoing treatment for hair loss. The steps of themethod include preparing any of the topical compositions describedherein; moistening the scalp and/or hair of the subject; blending thecomposition; applying the composition to the moistened scalp and/orhair; massaging the composition into the scalp and/or hair (for example,by using a circular motion); leaving the composition on the scalp and/orhair for a period of time; and rinsing the composition from the scalpand/or hair.

As used herein, the terms “treat” and “treating” refer to the reduction,slowing, stopping, limiting, and/or elimination of hair loss (alopecia).The treatment may also improve hair quality and texture so as tominimize effects of hair loss (alopecia) on appearance.

As used herein, a “subject” or “person” is any human being experiencinghair loss and/or any human being in need of treatment for such hairloss.

In addition to human beings, animals can also suffer from a variety ofdermatologic conditions causing and/or resulting in hair loss. Thus, theterm “subject” also encompasses animals.

When carrying out the method, the composition may be left on the scalpand/or in the hair for any period of time deemed necessary. However, thepreferred range is a time period of at least two to five minutes.

The method may be carried out on a daily basis, every day, weekly, orany other time intervals deemed to be effective in providing the desiredimprovements.

The method encompasses applying a shampoo, a conditioner, a tonic, acombination shampoo/conditioner, and a combinationshampoo/conditioner/tonic. Any of these may be “leave-in” meaning thatthey are combed or brushed throughout areas of the scalp and/or hair andare left on the scalp and/or hair and not rinsed out.

Accordingly, it is therefore an objective of the invention to providecompositions and methods for treating hair loss (alopecia, balding).

It is an objective of the invention to provide compositions for topicalapplication to the scalp and/or hair.

It is another objective of the invention to provide a product forbalding and/or hair loss that does not require a prescription fordistribution or use, i.e. the product is over-the-counter.

It is yet another objective of the invention to provide a compositionthat improves hair quality and texture so as to minimize effects of hairloss (alopecia) on appearance.

It is another objective of the invention to provide compositions fortreating hair loss by reducing the effects of 5α-dihydrotestosterone(DHT).

It is another objective of the invention to provide compositions fortreating hair loss including three natural, active ingredients,caffeine, saw palmetto berry extract/derivative, andepigallocatechin-3-gallate (EGCG).

It is yet another objective of the invention to provide a formulation ofDHT blockers in solution having beneficial effects in hair losspatients.

It is still another objective of the invention to provide a compositionfor topical application to a human scalp including about 0.01 to about0.19 mg/ml of caffeine, which is about 0.001% to about 0.019% weight ofcaffeine/final volume; about 0.01 to about 0.2 mg/ml of a saw palmettoberry derivative, which is about 0.001% to about 0.02% weight of sawpalmetto berry derivative/final volume; and about 0.5 to about 50 mg/mlof an epigallocatechin-3-gallate (EGCG) derivative, which is about 0.05%to about 5% weight of EGCG/final volume.

It is another objective of the invention to provide a method fortreatment of hair loss including the steps of preparing any of thetopical compositions described herein; moistening the scalp and/or hairof the subject; blending the composition; applying the composition tothe moistened scalp and/or hair; massaging the composition into thescalp and/or hair (for example, by using a circular motion); leaving thecomposition on the scalp and/or hair for a period of time; and rinsingthe composition from the scalp and/or hair.

Although the invention is described herein as embodied in a combinationof natural products (caffeine, saw palmetto berry derivative, andepigallocatechin-3-gallate (EGCG) derivative) for hair loss patients, itis, nevertheless, not intended to be limited to the details describedbecause various modifications and structural changes may be made thereinwithout departing from the spirit of the invention.

Thus, the above embodiments, features, and objectives are merelyexemplary of the invention. Other objectives and advantages of thisinvention will become apparent from the following description ofspecific formulations.

DETAILED DESCRIPTION OF THE INVENTION

For the purpose of promoting an understanding of the principles of theinvention, reference will now be made to embodiments illustrated hereinand specific language will be used to describe the same. It willnevertheless be understood that no limitation of the scope of theinvention is thereby intended. Any alterations and further modificationin the described compositions, methods, products, kits, and/or anyfurther application of the principles of the invention as describedherein, are contemplated as would normally occur to one skilled in theart to which the invention relates.

The instant invention provides a topical, natural, and safe composition(and methods of use thereof) that will improve hair loss treatment,including treatment in men (androgenic alopecia) and treatment inpost-menopausal women (female-pattern hair loss).

A relationship between testosterone levels and hair loss has beenwell-described in the pathogenesis of this distressing condition.Blockers of testosterone and its metabolite, 5α-dihydrotestosterone(DHT), have been used systematically to treat male-pattern hair loss.

Caffeine, saw palmetto berry extract, and epigallocatechin-3-gallate(EGCG) have found to have varying effects on 5α-dihydrotestosteronethrough different mechanisms.

Fischer (Fischer et al. Int J Dermatol. 46(1):27-35 2007) demonstratedthe effect of caffeine and testosterone on the proliferation of humanhair follicles in vitro. Significant growth suppression was found inhair follicles treated with 5 mg/ml testosterone. This suppression wascounteracted by caffeine in concentrations of 0.001% and 0.005%.Additionally, caffeine alone led to significant stimulation of hairfollicle growth.

In medical literature to date, these observations have not been reportedwith topical preparations of caffeine in vivo.

Topical preparations using caffeine in high concentrations of about 1%of weight per unit volume or greater has a vasoconstrictive effect.Vasoconstriction is understood to decrease blood flow to the hairfollicles, and thereby, inhibit hair growth. Thus, using caffeine forhair loss prevention in vivo is not found in the art. The presentinvention uses a concentration of caffeine (about 0.01 to about 0.19mg/ml of caffeine, which is about 0.001% to about 0.019% weight ofcaffeine/final volume) that avoids vasoconstriction, but maintains itsreducing effects on 5α-dihydrotestosterone (DHT).

Saw palmetto (Serenoa repens or Sabal serrulata) is a dwarf palm plantnative to North America growing primarily along the southern Atlanticcoast of the United States. An extract has been derived from the berriesof this palm plant (saw palmetto berry extract) which has been usedorally for its effects on testosterone and dihydrotestosterone inprostate disease such as benign prostate gland enlargement (benignprostatic hyperplasia, BPH). Although it has not been scientificallyconfirmed, it is believed that saw palmetto berry extract may block the5-α-reductase enzyme from converting testosterone intodihydroxytestosterone. See “Can Saw Palmetto Stop Hair Loss?” by CathyWong at the About.com website under “Alternative Medicine”; accessed onJan. 31, 2012.

Considering that saw palmetto berry extract has been used orally for itseffects on testosterone and dihydroxytestosterone in the treatment ofprostate disease, it is a potentially-beneficial treatment for alopecia(hair loss). Saw palmetto berry extract can be used in combination witha low concentration of caffeine to reduce the effects ofdihydroxytestosterone and thereby, treat alopecia (hair loss).

Epigallocatechin-3-gallate (EGCG) is a natural polyphenolic compoundfound in green tea. It has been reported that EGCG may be useful forselectively inhibiting 5-α-reductase activity and several studies havedemonstrated its effects on hair growth.

Hiipakka (Hiipakka et al. Biochemical Pharmacology 63(6):1165-1176 2002)showed that epigallocatechin-3-gallate (EGCG) potently inhibited human5-α-reductase in cell free but not in whole cell assays in vitro.

Kwon (Kwon et al. Phytomedicine 14:551-555 2007) showed that in vitroexposure of human hair to topical EGCG demonstrated changes that wereconsistent with in vivo changes for cell proliferation markers inpathways known to participate in growth. Thus, Kwon suggested that EGCGstimulates human hair growth. Kwon's formula contained EGCG in 10%ethanol which was used in human volunteers. This formulation is notuseful for repeated topical application due to the irritant and otherside effects of the 10% ethanol.

Esfandiari (Esfandiari et al. Journal of the National MedicalAssociation 97(8):1165-1169 2005) showed, using a mouse model for hairloss, that mice given green tea in their drinking water had a 33% hairre-growth rate compared to mice receiving unsupplemented drinking water.

Green tea extracts have not been widely considered as effective fortopical delivery as the extracts rapidly degrade in aqueous solution andare unlikely to penetrate an intact epidermal barrier. Hsu, S. Journalof the American Academy of Dermatology 52(6):1049-1059 2005.Additionally, even high topical concentrations failed to deliversignificant levels in preliminary studies.

Thus, although caffeine, saw palmetto berry extract, andepigallocatechin-3-gallate (EGCG) have been shown to have similareffects, they have never been used together prior to the instantinvention. There are no published reports in the scientific literaturethat demonstrate direct effects of topical EGCG in humans undergoinghair loss therapy. Additionally, there are no published reports in themedical literature that topical formulation of caffeine changed levelsof testosterone or dihydroxytestosterone to suggest that topicaltreatment might have an effect on hair loss. Further, saw palmetto berryextract has not been shown to have effects in topical formulations.

Accordingly, no studies or reports have been shown to use these threecompounds (caffeine, saw palmetto berry extract, and EGCG)simultaneously to reduce the effects of dihydroxytestosterone (DHT) onthe complex DHT receptor expressed on hair follicles, which effectstrigger female and male-pattern hair loss. Further, these threecompounds (caffeine, saw palmetto berry extract, and EGCG) have beeningested internally for years without any reports of hair growth. Thecombination of these three compounds has the potential for a synergisticeffect for hair loss prevention and/or hair growth promotion byinterfering with the DHT receptor.

The invention is a topical formulation, utilizing caffeine, saw palmettoberry extract, and EGCG in combination, and provides a product for usein treatment of hair loss/balding that does not require a prescriptionfor distribution or use.

Caffeine, saw palmetto berry extract, and EGCG are all known to haveminimal side effects when used internally. Worldwide, caffeine isbelieved to be the most commonly ingested drug and tea is believed to beone of the most frequently ingested liquid beverages. Therefore, topicalor local application of the invention is expected to be safe, as chronicoral exposure to these compounds is considered safe.

FORUMULATIONS EXAMPLE 1

The first formulation, found in to U.S. Utility Patent Application No.11/242,207, filed on Oct. 3, 2005, included two topicaldihydroxytestosterone (DHT) blockers, caffeine and a saw palmetto berryextract. Approximately 2400 bottles were manufactured and sold withgreat patient satisfaction and return of patients to purchase more.Significant clinical improvement was observed by experienceddermatologists with this formulation.

The reduction of the previous caffeine concentration, an increase in sawpalmetto extract concentration, and addition ofepigallocatechin-3-gallate (EGCG) (a potent naturally-occurring DHTblocker) were contemplated to enhance the hair growth product.

EXAMPLE 2

The updated formulation, found in U.S. Provisional Patent ApplicationNo. 61/441,063, filed on Feb. 9, 2011, included about 0.01 to 0.19 mg/mlof caffeine (about 0.001% to 0.019% weight of caffeine/final volume);about 0.01 to 0.2 mg/ml of saw palmetto berry extract (about 0.001% to0.02% weight of saw palmetto berry extract/final volume); and about 75to 150 mg/ml epigallocatechin-3-gallate (EGCG) (about 7.5% to 15% weightof EGCG/final volume).

EGCG in high concentration was found not to be feasible due tosolubility problems. The separation of EGCG from the solution led toreductions in concentration.

EXAMPLE 3

The current formulation, described herein, includes about 0.01 to 0.19mg/ml of caffeine (about 0.001% to 0.019% weight of caffeine/finalvolume); about 0.01 to 0.2 mg/ml of saw palmetto berry extract (about0.001% to 0.02% weight of saw palmetto berry extract/final volume); andabout 0.5 to 50 mg/ml epigallocatechin-3-gallate (EGCG) (about 0.05% to5% weight of EGCG/final volume).

The current formulation may affect local levels of androgenic hormones(i.e. testosterone and dihydroxytestosterone). Thus, it is recommendedthat this formulation be used only on men and women of non-childbearingpotential considering that it has not been evaluated in women ofchildbearing ability.

EXAMPLE 4

The current formulation is commercially available as a shampoo. Thisshampoo includes the following ingredients: D1 water, Sodium C14-16Olefin Sulfonate, Cocamidopropyl Betaine, Cocamide DEA, Dimethiconoldodecylbenzensulfonate, TEA dodecylbenzensulfonate, Glycol Distearate,Sodium Chloride, Fragrance, Hydrolyzed Wheat Protein, GuarHydroxypropyltrimonium Chloride, Epigallocatechin Gallate, Panthenol,Methylchloroisothiazolinone, Methylisothiazolinone, Caffeine, SerenoaSerrulata Fruit Extract, and Citric Acid.

EXAMPLE 5 Clinical Case Studies

Over 1500 bottles of a commercial embodiment of the describedcomposition (Pilaris Max® Shampoo) have been sold with continualmultiple repeat orders. Positive results have been reported.

Study One: A 55-year old white male in the end stage of male-patternhair loss (Hamilton IV) began using a commercial embodiment of thedescribed composition (Pilaris Max® Shampoo) in July 2011. He used theshampoo every morning after swimming. He applied the shampoo to hismoist scalp after swimming and leaves it on for a time period of fifteenminutes. Within a few weeks he noticed baby fine hairs appearing on hisscalp. These baby fine hairs later converted to mature hairs over thenext two months to the point where he required a haircut to the top ofhis head for the first time in years. He developed enough hair on thetop of his head to the level that he began using hair color products.His co-workers and friends thought he had had a hair transplant.

Study Two: A 50-year old male began using a commercial embodiment of thedescribed composition (Pilaris Max® Shampoo) in July 2011. He appliedthe shampoo to his scalp for the duration of his daily shower and anyadditional showers intermittently. He noticed a significant change froma photo taken in June 2011 before he began using the shampoo. Inaddition, a dermatologist he has known for sixteen years said “I haveknown you for years and you had significant thinning of the hair on topof your head, your hair is thicker now, so I know you have had hairtransplants.”

All patents and publications mentioned in this specification areindicative of the level of those skilled in the art to which theinvention pertains. All patents and publications are herein incorporatedby reference to the same extent as if each individual publication wasspecifically and individually indicated to be incorporated by reference.It is to be understood that while a certain form of the invention isillustrated, it is not intended to be limited to the specific form orarrangement herein described and shown. It will be apparent to thoseskilled in the art that various changes may be made without departingfrom the scope of the invention and the invention is not to beconsidered limited to what is shown and described in the specification.One skilled in the art will readily appreciate that the presentinvention is well adapted to carry out the objectives and obtain theends and advantages mentioned, as well as those inherent therein. Thecompositions, formulations, methods, techniques, systems, programs, andkits described herein are presently representative of the preferredembodiments, are intended to be exemplary and are not intended aslimitations on the scope. Changes therein and other uses will occur tothose skilled in the art which are encompassed within the spirit of theinvention. Although the invention has been described in connection withspecific, preferred embodiments, it should be understood that theinvention as ultimately claimed should not be unduly limited to suchspecific embodiments. Indeed various modifications of the describedmodes for carrying out the invention which are obvious to those skilledin the art are intended to be within the scope of the invention.

What is claimed is:
 1. A method for treating hair loss by reducingeffects of 5α-dihydrotestosterone (DHT) in a subject undergoingtreatment for hair loss, the method comprising: a) providing acomposition consisting of about 0.01 to about 0.19 mg/ml of caffeine,which is about 0.001% to about 0.019% weight of caffeine/final volume;about 0.01 to about 0.2 mg/ml of a saw palmetto berry derivative, whichis about 0.001% to about 0.02% weight of saw palmetto berryderivative/final volume and about 0.5 to about 50 mg/ml of anepigallocatechin-3-gallate (EGCG) derivative, which is about 0.05% toabout 5% weight of EGCG/final volume; D1 water, Sodium C14-16 OlefinSulfonate; Cocamidopropyl Betaine; Cocamide DEA; Dimethiconoldodecylbenzensulfonate; TEA dodecylbenzensulfonate; Glycol Distearate;Sodium Chloride; Fragrance; Hydrolyzed Wheat Protein; GuarHydroxypropyltrimonium Chloride; Panthenol; Methylchloroisothiazolinone;Methylisothiazolinone; and Citric Acid; b) moistening the scalp and hairof the subject undergoing treatment for hair loss; c) applying thecomposition to the scalp and hair moistened in step b; d) massaging thecomposition into the scalp and hair; e) leaving the composition on thescalp and hair for a period of time, whereby the composition penetratesthe scalp to reduce effects of 5α-dihydrotestosterone (DHT) in thesubject undergoing treatment for hair loss; and f) rinsing thecomposition from the scalp and hair.
 2. The method of claim 1, whereinthe period of time is from about two to about five minutes.
 3. A methodfor treating hair loss by reducing effects of 5α-dihydrotestosterone(DHT) in a subject undergoing treatment for hair loss, the methodcomprising: a) providing a composition consisting of about 0.01 to about0.19 mg/ml of caffeine, which is about 0.001% to about 0.019% weight ofcaffeine/final volume; about 0.01 to about 0.2 mg/ml of a saw palmettoberry derivative, which is about 0.001% to about 0.02% weight of sawpalmetto berry derivative/final volume and about 0.5 to about 50 mg/mlof an epigallocatechin-3-gallate (EGCG) derivative, which is about 0.05%to about 5% weight of EGCG/final volume; D1 water, Sodium C14-16 OlefinSulfonate; Cocamidopropyl Betaine; Cocamide DEA; Dimethiconoldodecylbenzensulfonate; TEA dodecylbenzensulfonate; Glycol Distearate;Sodium Chloride; Fragrance; Hydrolyzed Wheat Protein; GuarHydroxypropyltrimonium Chloride; Panthenol; Methylchloroisothiazolinone;Methylisothiazolinone; and Citric Acid; b) moistening the scalp and hairof the subject undergoing treatment for hair loss; c) applying thecomposition to the scalp and hair moistened in step b; d) massaging thecomposition into the scalp and hair; e) leaving the composition on thescalp and hair, whereby the composition penetrates the scalp to reduceeffects of 5α-dihydrotestosterone (DHT) in the subject undergoingtreatment for hair loss; and the composition is not rinsed from thescalp or hair.
 4. The method according to claim 3, wherein thecomposition is a leave-in conditioner.